3 Dimensional Ultrasound in Comparison to Hysteroscopy in Myomas

Fibroid Clinical Trial

Official title:

3 Dimensional Ultrasound in Comparison to Hysteroscopy in Diagnosis of Myomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04736095
• Other study ID #: 3D
• Status: Completed
• Start date: February 7, 2021
• Est. completion date: May 17, 2021

Study information

• Verified date: May 2021
• Source: Aljazeera Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• three-dimensional saline infusion sonohysterography (3D SIS) was performed in all cases. A sterile Cuscoe speculum was passed, the cervix visualized and cleaned with sterile chlorhexidine solution. A 3.3 mm soft plastic paediatric naso-gastric suction catheter was then passed through the cervix into the uterine cavity without grasping the cervix.

Description:

The speculum was removed and a 5 MHz transvaginal 3D ultrasound probe inserted into the vagina (Voluson 730; KretzTechnik, Austria).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 17, 2021
• Est. primary completion date: May 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• • Women between 20 and 60 years with abnormal uterine bleeding in form of heavy menstrual bleeding, irregular and heavy menstrual bleeding) diagnosed on non-enhanced two-dimensional ultrasonography with submucous fibroids.

• Absence of STD, PID, active vaginal bleeding.

Exclusion Criteria:

• Presence of general cause of abnormal uterine bleeding

• History of drug use that can cause vaginal bleeding (anticoagulants, OCPs, HRT)

• History of recent hormonal treatment

• High risk of undergoing hysteroscopy

• Vaginal, Vulval causes of bleeding

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma

Intervention

Diagnostic Test:
• 3D Ultrasound
Doing 3D ultrasound for diagnosis of submucous myoma
• Hysteroscopy
Doing hysteroscopy for diagnosis of submucous myoma

Locations

Country	Name	City	State
Egypt	Algazeerah	Giza
Egypt	Aljazeera( Al Gazeera) hospital	Giza

Sponsors (2)

Lead Sponsor	Collaborator
Aljazeera Hospital	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The accuracy of 3D ultrasound in doiagnosis of submucous myomas in comparison to hysteroscopy	How many women will be diagnosed by 3D US to have submucous myoma	one week